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Barhemsys

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Janssen and Legend Biotech’s Carvykti receives FDA approval for patients with relapsed or refractory multiple myeloma

In the study, 98% of patients with relapsed or refractory multiple myeloma responded to a one-off treatment of the drug

Biomarin

FDA keeps BioMarin’s gene therapy for phenylketonuria on hold

The decision follows data suggesting BioMarin’s experimental gene therapies may have the potential to progress cancers

- PMLiVE

Eli Lilly’s Omicron drug treatment gets emergency use authorisation from FDA

The drug can be used to treat adults with mild-to-moderate COVID-19, and children aged 12 or older, in specific emergency cases in non-hospital settings

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FDA accepts Priority Review for Dupixent in children with moderate-to-severe atopic dermatitis

If approved, Dupixent would be the first biologic treatment available in the US for children aged six months to five years with the skin condition

- PMLiVE

FDA issues approval for Sanofi’s Enjaymo treatment for patients with CAD

The treatment is the first-of-its-kind for patients living with cold agglutinin disease, a rare blood disorder

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FDA issues approval for Janssen’s HIV drug Cabenuva

The injectable treatment for adults with HIV can be administered every two months

- PMLiVE

FDA places partial clinical hold on three Gilead phase 3 trials for MDS and AML treatments

The company confirmed that six other phase 2 trials would go ahead as previously planned

- PMLiVE

FDA restricts use of certain antibody treatments for COVID-19

The restrictions reflect recent data that shows these antibodies are not effective against the Omicron variant

- PMLiVE

FDA grants priority review for Roche’s Evrysdi for spinal muscular atrophy in babies

The review of Evrysdi has been developed for pre-symptomatic babies under two months old with spinal muscular atrophy

- PMLiVE

Gilead’s Veklury receives FDA approval for non-hospitalised high-risk patients to treat COVID-19

The FDA also issued an EUA for the treatment to include non-hospitalised paediatric patients 12 years and under who are at high risk of disease progression

- PMLiVE

AstraZeneca’s Enhertu receives FDA grant for priority review

The approval is based on results from the DESTINY-Breast03 trial which showed a significant risk reduction of unresectable or metastatic HER-2 positive breast cancer progression

- PMLiVE

Pfizer’s Cibinqo granted FDA approval for adults with moderate-to-severe atopic dermatitis

The FDA based its approval on results from a clinical trial programme involving over 1,600 patients

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